Marcaine Spinal 0.5% Heavy

/ Perrigo

Marcaine Spinal Heavy should only be used by clinicians with experience of regional anaesthesia or under their supervision. The lowest possible dose for adequate anaesthesia should be used.
The doses given below are guides for adults and the dosage should be adjusted to the individual patient.
The dose should be reduced in elderly patients and patients in late stages of pregnancy.
For dosage guidlines please refer to doctor’s leaflet.
The recommended injection is in the L3-L4 intervertebral space.
There is currently no experience of doses higher than 20 mg.
A spinal injection is given only after the subarachnoid space has been clearly identified by means of lumbar puncture (clear cerebrospinal fluid runs out via the spinal needle or is seen on aspiration). In the event of unsuccessful anaesthesia, a new attempt to administer the drug should only be made by
injecting at a different level and with a smaller volume. One cause of lack of effect may be poor intrathecal distribution of the drug, and this can be helped by altering the patient’s position.

Spinal anaesthesia for surgery, e.g. urological surgery and surgery, on the lower limbs, lasting 2-3 hours, abdominal surgery lasting 45-60 minutes.

Hypersensitivity to the active substance, amide-type local anaesthetic agents or to any of the excipients. Diseases of the central nervous system (e.g. meningitis, tumours, poliomyelitis, cranial haemorrhage). Local suppurative infections at or near the injection site.
Spinal stenosis and active disease (e.g. spondylitis, tumour, tuberculosis) or trauma (e.g. spinal fracture).
Septicaemia. Pernicious anaemia with subacute degeneration of the spinal cord. Spinal anaesthesia should not be given to patients in shock. Spinal anaesthesia should also not be given to patients with coagulation disorders or to patients with on-going anticoagulation treatment.

See prescribing information for full details.

Side effects caused by the medicinal product itself can be difficult to distinguish from the physiological effects of the nerve blockade (e.g. fall in blood pressure, bradycardia, temporary urinary retention), events caused directly by the needle puncture (e.g. spinal haematoma) or caused indirectly by the needle puncture (e.g. meningitis, epidural abscess) or events associated with cerebrospinal leakage (e.g. post-dural-puncture headache).
See prescribing information for full details.

Bupivacaine should be used with caution with other local anaesthetic agents or medicinal products structurally similar to local anaesthetic agents, i.e. class IB antiarrhythmic agents, as the toxic effects are additive.
Specific interaction studies have not been performed with local anaesthetic agents and class III antiarrhythmic agents (e.g. amiodarone), but caution is recommended.

Pregnancy: No known risks for the foetus when used during pregnancy. However, note that the dose should be reduced for patients in the late stages of pregnancy.
Breast-feeding: Bupivacaine passes into breast milk, but the risk of an effect on the child seems unlikely at therapeutic doses.

See prescribing information for full details.